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Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

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ClinicalTrials.gov Identifier: NCT03981510
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
To gain a better understanding of the underlying dysmotility in constipation in children, we will use a novel minimal invasive method called 3D Transit. We will examine four groups of children aged 7 to 12 years: healthy children, chronically constipated children (ROM IV criteria), children with neurofibromatosis type 1 and finally children receiving chemotherapy (vincristin) for acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Constipation Childhood Acute Lymphoblastic Leukemia Neurofibromatosis 1 Chronic Constipation With Overflow Diagnostic Test: 3D-Transit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Children being investigated with 3D-transit

4 groups of each 20 children will be investigated with respectively one or two capsules:

  • Healthy children (1)
  • Children with chronic constipation (2)
  • Children with neurofibromatosis type 1 (2)
  • Children with cancer receiving treatment with Vincristine (1)
Diagnostic Test: 3D-Transit
3D transit investigation consists of a small electromagnetic pill and a detector located in a belt around the waist. The pill is swallowed by the participant and the belt is worn until the pill has left the gastrointestinal tract. The method is without any pain and discomfort for the child. The child will visit the hospital the first time to ingest the capsule alongside a standardized meal, and is then free to go home and proceed with daily activities (beside hard exersize) while wearing the belt with the detector. The next day, the child will again visit the hospital to check whether or not the capsule has left the tract - this is done with a computer and software. The children ingesting two capsules will do this with a certain delay.




Primary Outcome Measures :
  1. The investigation is without discomfort and adverse events. [ Time Frame: 3 days ]
  2. Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children. [ Time Frame: 3 days ]
  3. Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children. [ Time Frame: 3 days ]
  4. Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children. [ Time Frame: 3 days ]


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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Children aged 7-12 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria applicable to all participants:

• Children between 7-12 years of age where permission is granted for the participation by habitable parents with custody of the child. In case of joint custody, permission must be obtained from both parents.

Inclusion criteria applicable only to healthy participants:

• Gastrointestinal healthy children without chronic constipation

Inclusion criteria applicable only to constipated participants:

• Chronic constipation defined by Rom IV criteria, which is a diagnostic score for chronic constipation

Inclusion criteria applicable only to children in vincristine treatment:

• Children with cancer in treatment with vincristine

Inclusion criteria applicable only to patients with NF1:

• Diagnosis of NF1 with gastrointestinal symptoms

Exclusion Criteria:

  • Children with parents who are unable to understand the given particpant's information
  • Children with known dysregulated metabolic disease
  • Previously major intra-abdominal surgery
  • CNS surgery
  • Other treatment-requiring gastrointestinal disorder
  • Systemic steroid treatment within the last week
  • Children with difficulty swallowing
  • Children with known gastrointestinal obstruction or perforation
  • Acute infections
  • Diagnosed malabsorption including bile acid malabsorption
  • Menarche in girls

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981510


Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Klaus Krogh, professor, ph.d.    +45 23 38 59 37‬    klaukrog@rm.dk   
Contact: Christian Emil Brinck, medical student    +45 27110447    ceb@clin.au.dk   
Sponsors and Collaborators
University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03981510     History of Changes
Other Study ID Numbers: 3D-Transit Children AUH
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Constipation
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms